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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceON-X PROSTHETIC HEART VALVE
Generic NameHEART-VALVE, MECHANICAL
ApplicantOn-X Life Technologies, Inc.
1655 Roberts Blvd. NW
Kennesaw, GA 30144
PMA NumberP000037
Supplement NumberS036
Date Received06/03/2014
Decision Date10/28/2014
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR VERTICAL INTEGRATION OF A COMPONENT SUBSTRATE MANUFACTURING PROCESS.
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